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Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05610956
Collaborator
(none)
60
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

  • It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:

  1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).

  2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).

  • The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine.

. All patients will be subjected to the following:

  • Complete history taking.

  • Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.

  • Blood sample collection to assess:

  1. Routine Laboratory tests

  1. Complete blood picture (CBC).

  2. Liver functions (ALT, AST, Total and Direct Bilirubin).

  3. Kidney functions tests (Urea, serum creatinine).

  4. C-reactive protein.

  5. Fasting blood glucose.

  6. Urine analysis. B) Specific Laboratory tests

  7. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate kinase (9AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel randomized controlledparallel randomized controlled
Masking:
Double (Participant, Investigator)
Masking Description:
double blinded study
Primary Purpose:
Treatment
Official Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo group

Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.

Drug: conventional treatment
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
Experimental: empagliflozin group

Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.

Drug: Empagliflozin
Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.

Outcome Measures

Primary Outcome Measures

  1. clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. [4months]

    difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

Secondary Outcome Measures

  1. expression of TNFalpha [4months]

    difference between the two groups in TNFalpha

  2. expression of Adenosine monophosphate kinase (9AMPK ). [4months]

    difference between the two groups in Adenosine monophosphate kinase (9AMPK )

  3. expression of Fecal calprotectin [4months]

    difference between the two groups in fecal calprotectin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

•Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion Criteria:

  • Other inflammatory bowel diseases (CD).

  • History of serious hypersensitivity to empagliflozin or any component of the formulation.

  • Patients on dialysis.

  • Severe renal impairment (eGFR <20 ml/minute/1.73m2) .

  • Chronic urinary tract infection.

  • Chronic genital infection.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Youmna Hamdy, pharmacist, Tanta University
ClinicalTrials.gov Identifier:
NCT05610956
Other Study ID Numbers:
  • empagliflozin in UC
First Posted:
Nov 9, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Empagliflozin

Study Results

No Results Posted as of Nov 14, 2022